To confirm the performance and long term safety of MisagoPeripheral Self-Expanding Stent System for the treatment ofoccluded or stenotic Superficial Femoral or Popliteal arteries in thedaily practice
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Absence of clinically driven target lesion revascularization at 6 and 12 months
Secondary outcome
1. Technical success defined as a successful access and deployment of the
device with recanalisation determined by
less than 30% residual stenosis by angiography at the baseline procedure
2. Clinical success defined as technical success without the occurrence of
serious adverse events during procedure
3. Ankle-Brachial Index improvement of >= 0.1 (ABI before procedure compared
with ABI at discharge and at 6 and 12
months)
4. Primary and secondary patency rate (if duplex ultrasound available) defined
as <50% diameter reduction and peak
systolic velocity <2.4
5. Improvement of walking distance before procedure compared with walking
distance at discharge and at 6 and 12 months (if Treadmill test available)
6. Clinically driven Target Vessel Revascularization at 6 and 12
months
7. Major complications at 6 and 12 months, including amputation of the distal
part of the foot, the leg below the knee and the thigh
8. Vascular complications
9. Bleeding complications
10. The Rutherford classification of chronic limb ischemia at discharge and at
6 and 12 months post procedure
11. Stent Fracture at 6 and 12 months post procedure
Background summary
Currently, interventional procedures (balloon angioplasty and stenting) are the
first treatment to be proposed for most patients who have peripheral vascular
disease.This kind of pathology is frequently seen in elderly patients (up to
20% of the population above 65 years).
MISAGO is a new generation nitinol self expandable stents used for the
treatment of occluded superficial femoral artery (SFA) and Popliteal artery.
The product is CE marked.
Study objective
To confirm the performance and long term safety of Misago
Peripheral Self-Expanding Stent System for the treatment of
occluded or stenotic Superficial Femoral or Popliteal arteries in the
daily practice
Study design
Non-randomized, prospective, multicentre, observational registry.
Study burden and risks
The Registry only documents the treatment of the patient, therefore it does not
present any risk in addition to the standard risk of the procedure.
Interleuvenlaan 40
B-3001 Leuven
België
Interleuvenlaan 40
B-3001 Leuven
België
Listed location countries
Age
Inclusion criteria
Patients with documented symptomatic occlusion and/or >70%
stenosis of SFA or popliteal artery in one or both legs;1. Patients with symptomatic one or two legs ischemia, requiring
treatment of SFA or popliteal artery (2 or more by Rutherford
classification)
2. Single lesions per leg with recoiling/dissection/restenosis after
balloon angioplasty or de novo lesions with stenosis or occlusion,
which can be covered by maximum two stents
3. Target vessel reference diameter >=4mm and <=6mm (by visual
estimate)
4. Target lesion length should consider that maximum two Misago
stents can be implanted per lesion with recommended overlap 2
mm
5. At least one patent (less than 50% stenosis) tibioperoneal run-off
vessel confirmed by baseline angiography
6. Patient is suitable candidate for femoral-popliteal artery bypass
surgery
Exclusion criteria
Patient with any of the following should be excluded:
1. Pregnancy
2. Previous bypass surgery or stenting in the target vessel
3. Scheduled staged procedure of multiple lesions within the
ipsilateral iliac or popliteal arteries within 30 days after index
procedure
4. Co-existing aneurismal disease of the abdominal aorta, iliac or
popliteal arteries
5. Acute thrombophlebitis or deep venous thrombosis
6. Hemodynamic instability
7. Untreated inflow disease of the ipsilateral pelvic arteries (more
than 50 percent stenosis or occlusion),
8. Significant gastrointestinal bleeding or any coagulopathy that
would contraindicate the use of anti-platelet therapy
9. Known
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL21681.094.08 |